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Business Insights: Page 4
DermTech to lay off 30 employees, take further restructuring measures
By
LabPulse.com staff writers
DermTech will lay off 30 employees and take additional restructuring measures to cut operating expenses, streamline operations, and focus its resources on revenue growth.
February 1, 2024
Bruker eyes Chemspeed to accelerate entry into lab automation market
By
LabPulse.com staff writers
Basel, Switzerland-based Bruker announced that it plans to acquire Chemspeed to accelerate Bruker’s entry into the lab automation, digitalization, and scientific software solutions market.
February 2, 2024
Why many high-risk IVDs are being reclassified
By
LabPulse.com staff writers
The FDA announced that its Center for Devices and Radiological Health (CDRH) will reclassify most in vitro diagnostics (IVDs) that are in the high-risk category to moderate risk to allow their manufacturers an easier path to FDA clearance.
February 1, 2024
Oxford Nanopore, Lonza to collaborate on QC test for mRNA therapeutics
By
LabPulse.com staff writers
Oxford Nanopore will collaborate with biotech manufacturer Lonza on commercializing a cGMP-validated test to enable advanced analysis for quality attributes of mRNA products.
January 31, 2024
FDA orders new info warnings on CAR-T therapies
By
LabPulse.com staff writers
Following its review of reports of T-cell malignancies associated with the administration of six CAR-T immunotherapies, the FDA has instructed the manufacturers to include warnings in the prescribing info for the therapeutics.
January 30, 2024
Lab fraud repeat offender sentenced in $234M Medicare case
By
LabPulse.com staff writers
A clinical laboratory owner, operator, and manager was ordered to forfeit nearly $32 million, surrender his personal and business property in California, and serve 10 years in prison for his roles in clinical laboratory fraud.
January 31, 2024
Jury awards Natera $96.3M in patent infringement case against CareDX
By
LabPulse.com staff writers
A jury in the U.S. District Court for the District of Delaware has ruled in favor of Natera in its patent infringement case against CareDx, awarding the firm approximately $96.3 million in damages in a unanimous verdict.
January 29, 2024
BD, Techcyte team for AI-enabled digital cervical cytology system
By
LabPulse.com staff writers
Becton Dickinson (BD) and Techcyte have announced a strategic collaboration agreement designed to, in time, add artificial intelligence (AI) to cervical cancer screening in the U.S.
January 30, 2024
FDA accepts 1st AI-based tool into Istand pilot program
By
LabPulse.com staff writers
A mental health assessment tool has become the first AI-powered tool to be accepted into the U.S. Food and Drug Administration's (FDA) Innovative Science and Technology Approaches for New Drugs (Istand) pilot program for advancing drug development.
January 26, 2024
New bills sound alarms on foreign adversaries and medical diagnostics
By
LabPulse.com staff writers
Legislators wary of certain foreign biotech companies have introduced bipartisan, bicameral legislation that would ban federal contracts and funding mechanisms to companies with ties to foreign adversaries.
January 26, 2024
Precision medicine at tipping point with looming FDA LDT oversight
By
Liz Carey
FDA targets companion diagnostics (CDx) LDTs first. In addition, CAP and AdvaMedDx set clear expectations, and what to know about the FDA-CMS joint statement on FDA oversight.
January 25, 2024
Concentric by Ginkgo, Illumina to collaborate on biosurveillance technology
By
Matt Limb
Illumina and biosecurity firm Concentric by Ginkgo have pledged to expand biosecurity capabilities to help countries “modernize defenses" against emerging biological threats.
January 24, 2024
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